Elite Pharmaceuticals Files Anda with US FDA to Market Opiate Analgesic Product
September 25, 2023 at 06:00 am EDT
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Elite Pharmaceuticals, Inc. announced that it filed an Abbreviated New Drug Application (ANDA) on August 17, 2023, and was accepted for review by the US Food and Drug Administration (FDA) on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics. IQVIA reported annual sales for the twelve months ending June 2023 of $720 million for the brand and generic market for this product.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and distributes niche generic products. The Company specializes in developing and manufacturing oral, controlled-release drug products. It owns multiple generic products which has been licensed to Prasco, LLC and TAGI Pharma. The Companyâs segments include Abbreviated New Drug Applications (ANDA) and New Drug Application (NDA). The Companyâs products include Phentermine HCl 37.5mg tablets, Phendimetrazine Tartrate 35mg tablets, Phentermine HCl 15mg and 30mg capsules, Naltrexone HCl 50mg tablets, Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules and others.
ELITE PHARMACEUTICALS, INC. 
